The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed.

A young manager told me about the day she nearly quit her job. A major restructuring had left her team reeling. As targets shifted overnight, colleagues departed and rumors spread faster than facts.

What can we learn about human intelligence by studying how machines “think?” Can we better understand ourselves if we better understand the artificial intelligence systems that are becoming a more significant part of our everyday lives?

Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden.

I’ve been in and around the quality profession for decades. When I first started, we were most concerned about products failing in our customers’ hands... too often and too soon.

Have you ever been in line for a promotion or a transfer to a new role only to find out your boss was quashing your efforts to make that leap? Here are some tips on how to deal with a boss sabotaging your career.

Your company works hard to bring quality products to market, but your current inefficient development process slows you down.

Your facility has detailed standard operating procedures (SOPs), ISO certifications, and quality management systems that would impress any auditor.

The global coding- and marking-equipment market is on a clear growth path.

The term return to office (RTO) has dominated headlines for the past year.